Fibrin Sealant in Preventing Fluid Build Up During Surgery in Patients Undergoing Breast Reconstruction

NCT01649505 | Terminated Results DMC

• 2 other identifiers: IRB00006606NCI-2012-00809
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the efficacy of an alternative surgical technique and the use of fibrin sealant in preventing post-operative seroma formation. A seroma is a build-up of clear bodily fluids in a place on the body where tissue has been removed by surgery. Seromas can happen after breast surgeries. Seromas can appear about 7 to 10 days after surgery, after the drainage tubes have been removed. The breast area involved in the surgery may have a spot that's swollen and feels like there is liquid under the skin

Conditions

Breast Cancer; Perioperative/Postoperative Complications

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients in Each Arm Who Develop Post-operative Seromas

  Computed with 95% confidence interval using exact method. The difference of seroma rate in the two groups will be computed with 95% confidence interval using exact method. Two-sided Fisher's exact test will be used to evaluate whether the seroma rate are significantly different for the two treatment groups.

  Up to day 180 post-operation

Secondary Outcomes (3)

• Proportion of Patients Who Experienced Wound Infections, Wound Separation, or Any Other Surgical Complications

  Up to day 180 post-operation

• Quantity of Post-operative Drainage

  Up to day 10 post-operation

• Serious and Nonserious Adverse Events and Complications

  Up to day 180 post-operation

Study Arms (2)

Arm I (fibrin sealant)

EXPERIMENTAL

Patients undergo sharp dissection technique with fibrin sealant closure.

Drug: fibrin sealant (Beriplast P, TISSEEL VH); Procedure: breast reconstruction

Arm II (standard electrocoagulation)

ACTIVE COMPARATOR

Patients undergo standard electrocoagulation dissection technique.

Procedure: breast reconstruction

Interventions

fibrin sealant (Beriplast P, TISSEEL VH) DRUG

Applied topically

Also known as: Beriplast P, TISSEEL VH

Arm I (fibrin sealant)

breast reconstruction PROCEDURE

Undergo sharp dissection technique

Also known as: Mammaplasty

Arm I (fibrin sealant)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who will be undergoing latissimus dorsi donor flap harvest reconstruction and evaluated by the Department of Plastic and Reconstructive Surgery at Oregon Health and Science University (OHSU)
• These patients will be undergoing reconstructive surgery for a mastectomy/wide local excision of breast cancer defect or other soft tissue defect resulting from trauma, infection, undesirable surgical outcome, oncologic resection, etc.
• Ability to understand and the willingness to sign a written informed consent document

You may not qualify if:

• Patients who will not qualify for latissimus dorsi donor flap reconstruction based on anatomical limitations specific the subjects respectively; to be evaluated by the plastic surgeon
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to fibrin glue sealant
• Patients with evidence of hematological disorders resulting in deficient coagulation whereby sharp dissection would result in undesirable bleeding otherwise performed more safely with electrosurgery

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• Oregon Health and Science University: collaborator

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Postoperative Complications

Interventions

Fibrin Tissue Adhesive; Mammaplasty

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fibrin; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Cosmetic Techniques; Therapeutics; Plastic Surgery Procedures; Surgical Procedures, Operative

Limitations and Caveats

Data was not collected due to early termination and very low accrual.

Results Point of Contact

• Title: Dr. Juliana Hansen
• Organization: Oregon Health and Science University

hansenju@ohsu.edu

503-494-4834

Study Officials

• Juliana Hansen

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 20, 2012
• First Posted: July 25, 2012
• Study Start: January 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: November 2, 2022
• Results First Posted: March 15, 2013

Record last verified: 2022-10

Locations

US (1)